FDAFDA · Food and drugs·Recall number Z-0989-2014
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Published February 26, 2014 · Recall initiated: December 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
- Lot
- 4 lots: 4505268906, 4505336973, 4505408485, 4505238953
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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